Comparison of Patient Controlled Analgesia (PCA) Versus Bolus Narcotic Therapy for the Treatment of Vaso-Occlusive Crisis (VOC)

PCA for Pain Control in Adults With Sickle Cell Disease in the Emergency Department (ED) Decreases Admission Rates Over Standard Bolus Therapy

This research is being done to find out the best way to give narcotics for pain relief in adults with sickle cell disease and painful crisis. This study is a comparison of two ways of giving narcotics. The first way is what occurs now in the Emergency Acute Care Unit (EACU) where patients are given a single intravenous (iv) dose of a narcotic which is repeated by the nurse as needed to control the pain. The second way is to provide a single iv dose of narcotic and then allow the patient to push a button and receive one or more additional doses of narcotic when he/she thinks it is needed. Our hypothesis is that PCA will be a more effective way of controlling pain.

Study Overview

• Status: Withdrawn
• Conditions: Sickle Cell Disease; Vaso-occlusive Crisis
• Intervention / Treatment: Procedure: Patient controlled analgesia; Drug: nurse-administered intermittent IV bolus opioid therapy (NAIBOD)

• Study Type: Interventional
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21205
      • Johns Hopkins Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Documented sickle cell disease
• Signed consent in outpatient clinic or during a prior hospitalization
• 18+ years of age
• Seen in the ED with sickle cell pain crisis - this will be based on patients chief complaint that they are in a VOC.
• Requires IV administration of narcotics (has failed oral narcotic therapy at home)
• Must be 2 weeks since their last randomization on this study.

Exclusion Criteria:

• Contraindication to the use of IV narcotics
• Hypotension with systolic blood pressure (SBP) ≤ 90
• Respiratory rate ≤9
• Altered mental status
• Patient unable to understand how to use the PCA device
• Patient unwilling to use PCA device
• Pulse oximeter reading of ≤ 94% on room air
• Patient is allergic to IV morphine & hydromorphone & fentanyl.
• Patient is allergic to oral hydromorphone & morphine & oxycodone
• Patient has been randomized on this study 3 times before

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: 1; In this arm patients will be randomized to receive a bolus of narcotic followed by PCA.	Procedure: Patient controlled analgesia; Patients in this arm will be treated with a bolus of narcotic followed by PCA
ACTIVE_COMPARATOR: 2; In this arm patients will be randomized to the current standard of care of bolus narcotic treatment.	Drug: nurse-administered intermittent IV bolus opioid therapy (NAIBOD); In this arm patients will receive the current standard of care of IV bolus narcotic therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Decrease in admissions for those treated with a PCA in the ED v those that are given bolus narcotic dosing	Measured at time of discharge from ED

Secondary Outcome Measures

Outcome Measure	Time Frame
Length of stay	Endpoints will be the time at which the decision for discharge from the EACU or transfer from the EACU to inpatient admission to the hospital is made
Total narcotic used	Endpoints will be the time at which the decision for discharge from the EACU or transfer from the EACU to inpatient admission to the hospital is made

Collaborators and Investigators

• Sponsor: Johns Hopkins University

Study record dates

Study Major Dates

• Study Start: September 1, 2007
• Primary Completion (ANTICIPATED): September 1, 2009
• Study Completion (ANTICIPATED): September 1, 2009

Study Registration Dates

• First Submitted: July 7, 2008
• First Submitted That Met QC Criteria: July 8, 2008
• First Posted (ESTIMATE): July 9, 2008

Study Record Updates

• Last Update Posted (ACTUAL): March 24, 2017
• Last Update Submitted That Met QC Criteria: March 22, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hematologic Diseases; Genetic Diseases, Inborn; Anemia; Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Hemoglobinopathies; Anemia, Sickle Cell; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Narcotics; Analgesics, Opioid
• Other Study ID Numbers: NA_00001163